Treatment of joint conditions

a joint condition and treatment method technology, applied in the field of joint condition treatment, can solve the problem of inflammation of joint conditions

Active Publication Date: 2016-02-18
AMPIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0024]Transdermal patches have the added advantage of providing controlled delivery of compounds of the invention to the body. Such dosage forms can be made by dissolving, dispersing or otherwise incorporating one or more compounds of the invention in a proper medium, such as an elastomeric matrix material. Absorption enhancers can also be used to increase the flux of the compound across the skin. The rate of such flux can be controlled by either providing a rate-controlling membrane or dispersing the compound in a polymer matrix or gel.

Problems solved by technology

Further, the joint condition can be inflammation.

Method used

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  • Treatment of joint conditions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0051]A randomized, placebo-controlled, double-blind study was performed to evaluate the efficacy and safety of two doses of intra-articular (IA) injection of Ampion™ in adults with pain due to osteoarthritis of the knee (OAK).

Primary Objective

[0052]To evaluate whether the efficacy of 10 mL Ampion™ versus 10 mL placebo is greater than the efficacy of 4 mL Ampion™ versus 4 mL placebo IA injection in improving knee pain, when administered to patients suffering from OAK.

Study Subjects

[0053]Study subjects were male and female adult patients who were 40 years to 85 years old (inclusive). Eligible patients were ambulatory but suffering from moderate to moderately severe pain from OAK in the index knee, as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1, five-point Likert Pain Subscale at screening. Patients must have had an index knee that was symptomatic for greater than six months with a clinical diagnosis of OAK, which was supported by radiological evidence (Kellgren-Lawre...

example 2

[0072]A prospective Phase I / II study was performed to evaluate the safety and efficacy of three intra-articular injections of Ampion™ (4 mL) administered two weeks apart in adults with pain due to osteoarthritis of the knee.

Primary Objectives

[0073]The primary objective of Phase I was to evaluate the safety of Ampion™ 4 mL administered as three IA injections, two weeks apart, in patients suffering from OAK of the knee from baseline to Week 20.

[0074]The primary objective of Phase II was to evaluate the safety and efficacy of Ampion™ 4 mL versus placebo injection from baseline to Week 20, when administered as 3 IA injections, in improving knee pain in patients suffering from OAK of the knee.

Study Subjects

[0075]For both the Phase I and Phase II studies, subjects were male and female adult patients who were 40 years to 85 years old (inclusive) with OAK knee pain. Eligible patients were required to be ambulatory and the index knee must have been symptomatic for greater than six months wit...

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Abstract

The invention provides a method of treating a joint condition. The method comprises administering a multi-dose regimen of a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP). The invention also provides a method of treating osteoarthritis with multiple doses of a low-molecular weight fraction of human serum albumin.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 62 / 038,682, filed 18 Aug. 2014, the entirety of which is hereby incorporated by reference.FIELD OF INVENTION[0002]The invention relates to a method of treating a joint condition. The method comprises administering an effective amount of a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP). The invention also provides the use of a pharmaceutical product comprising DA-DKP.BACKGROUND[0003]Osteoarthritis is the most common form of arthritis, affecting 25 to 35 million people in the U.S. Chronic pain and disability of osteoarthritis is initially caused by inflammatory responses in joint cartilage and bone that gradually worsens over time. Symptomatic osteoarthritis of the knee occurs in 10 to 13% of persons aged 60 and over. Knee osteoarthritis alone increases the risk of loss of mobility, such as need...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/495A61K38/38A61K45/06
CPCA61K31/495A61K38/385A61K45/06A61K38/38A61P19/00A61P19/02A61P29/00A61P43/00A61K38/28A61K31/496
Inventor BAR-OR, DAVID
Owner AMPIO PHARMA
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